Tools, Systems, and Methods for Remodeling Tissue

• US 20130110226A1
• Filed: 09/13/2012
• Published: 05/02/2013
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gurskis, Donnell W.
• Granted Patent: US 9,254,190 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A tool for remodeling a tissue annulus includes an elongate handle and a reshaping element on a distal end of the handle. The reshaping element may be directable between a first configuration to facilitate direction through a tissue annulus, and a second curved configuration to remodel tissue adjacent the tissue annulus. The tool may be used for treating a tissue annulus within a patient'"'"'s heart, e.g., by introducing the reshaping element through the tissue annulus, and manipulating the tool to reshape the tissue annulus substantially to a contour of the reshaping element. The reshaping element may support the tissue while a prosthesis is secured to the tissue annulus, or the reshaping element may itself be secured to the tissue annulus and released from the tool.

Claims

1. A tool for treating a mitral valve annulus of a heart, comprising:

a substantially rigid handle comprising proximal and distal ends and having a length sufficient to access a mitral valve annulus from outside a patient'"'"'s body via an opening in the patient'"'"'s chest;

a reshaping element extending from the distal end of the handle and terminating in a substantially atraumatic distal tip, the reshaping element being directable to a curved configuration defining a radius of curvature to extend partially around the mitral valve annulus for remodeling tissue surrounding the mitral valve annulus.

2. The tool of claim 1, further comprising an actuator on the proximal end of the handle and coupled to the reshaping element for directing the reshaping element from a relaxed configuration to facilitate introduction between leaflets of the mitral valve to the curved configuration.

3. The tool of claim 2, wherein the radius of curvature of the reshaping element is non-uniform along a length of the reshaping element in the curved configuration.

4. The tool of claim 2, further comprising an actuator member extending from the proximal end of the handle to the distal tip, the actuator coupled to the actuator member for pulling the actuator member to cause the reshaping element to be directed from the first configuration to the second configuration.

5. The tool of claim 4, wherein the reshaping element comprises a plurality of segments aligned adjacent one another to define a passage, the actuator member received through the passage and coupled to the distal tip such that pulling the actuator member causes the plurality of segments to compress to direct the reshaping element from the first configuration to the second configuration.

6. The tool of claim 5, wherein the reshaping element comprises an elongate member defining a central longitudinal axis and extending between the distal tip and the distal end of the handle, the actuator member slidably coupled to the elongate member at one or more locations between the distal tip and the distal end of the handle and offset from the central axis such that a proximal tension applied to the actuator member causes the elongate member to bend towards the second shape.

7. The tool of claim 6, wherein the elongate member comprises at least one of a fabric roll, and a core member at least partially covered by fabric.

8. The tool of claim 1, wherein the reshaping element is releasable from the distal end of the handle.

9. The tool of claim 2, wherein the reshaping element is releasable from the distal end of the handle, the handle comprising one or more connectors for releasably attaching a proximal end of the reshaping element to the distal end of the handle.

10. The tool of claim 9, wherein the reshaping element comprises:

an actuator member coupled to the distal tip and extending proximally along the reshaping element to the reshaping element proximal end; and

a locking element on the reshaping element proximal end that receives the actuator member therethrough such that the actuator member is slidable proximally through the locking element to allow tension to be applied to the actuator member by the actuator to direct the reshaping element towards the second configuration yet limit release of the tension to prevent the reshaping element from returning towards the first configuration.

13. The tool of claim 1, wherein the reshaping element is directable between a first configuration to facilitate direction through a tissue annulus, and a second curved configuration to remodel tissue adjacent the tissue annulus.

14. The tool of claim 13, wherein the reshaping element defines a portion of a circle in the second configuration.

15. The tool of claim 13, further comprising an actuator on the proximal end of the handle coupled to the reshaping element for directing the reshaping element between the first and second configurations.

16. The tool of claim 15, further comprising an actuator member extending from the proximal end of the handle to the distal tip, the actuator coupled to the actuator member for pulling the actuator member to cause the reshaping element to be directed from the first configuration to the second configuration.

17. The tool of claim 16, wherein the reshaping element comprises a plurality of segments defining a passage, the actuator member received through the passage and fixed to the distal tip such that pulling the actuator member causes the plurality of segments to compress to direct the reshaping element from the first configuration to the second configuration.

18. The tool of claim 17, wherein the plurality of segments comprise at least one of cylinders, balls, and coil segments.

19. The tool of claim 13, wherein the reshaping element is flexible in the first configuration to facilitate introduction through a tissue annulus.

11. A tool for treating a tissue annulus, comprising:

an elongate handle including a proximal end and a distal end; and

a reshaping element on the distal end terminating in a distal tip and having a shape to remodel tissue adjacent a tissue annulus.

12. The tool of claim 11, wherein the distal tip has an atraumatic shape.

20. The tool of claim 11, wherein the reshaping element is releasable from the handle.

21. The tool of claim 20, wherein the reshaping element is at least partially covered with fabric.

22. The tool of claim 20, further comprising an actuator on the proximal end of the handle for releasing the reshaping element from the handle.

23. A system for treating a tissue annulus, comprising:

a tool comprising an elongate handle including a proximal end, a distal end, and a reshaping element extending from the distal end and terminating in a distal tip, the reshaping element having a shape to remodel tissue adjacent a tissue annulus; and

a plurality of fasteners receivable through tissue adjacent the tissue annulus.

24. The system of claim 23, further comprising a tool for delivering the fasteners into tissue adjacent the tissue annulus.

25. The system of claim 24, wherein the fasteners comprise clips.

26. The system of claim 24, wherein the fasteners are configured for securing the reshaping element on the tool to tissue adjacent the tissue annulus, and wherein the reshaping element is releasable from the handle.

27. The system of claim 23, further comprising a prosthesis configured for supporting the tissue annulus, the fasteners being receivable through the prosthesis for securing the prosthesis to tissue adjacent the tissue annulus.

28. The system of claim 27, wherein the prosthesis has at least one of an annular shape and a “

C”

shape.

29. The system of claim 23, wherein the reshaping element is directable between a first configuration to facilitate direction through a tissue annulus, and a second curved configuration to remodel tissue adjacent the tissue annulus.

30. The system of claim 29, further comprising:

an actuator on the proximal end of the handle coupled to the reshaping element for directing the reshaping element between the first and second configurations; and

an actuator member extending from the proximal end of the handle to the distal tip, the actuator coupled to the actuator member for pulling the actuator member to cause the reshaping element to be directed from the first configuration to the second configuration.

31. A method for treating a tissue annulus within a patient'"'"'s heart, comprising:

introducing a distal end of a remodeling tool through the tissue annulus; and

reshaping the tissue annulus substantially to a contour of the tool distal end.

32. The method of claim 31, wherein the tool distal end is introduced through the tissue annulus in a first configuration, and wherein reshaping the tissue annulus comprises:

directing the tool distal end to a second curved configuration below the tissue annulus; and

lifting tissue adjacent the tissue annulus using the tool distal end in the second curved configuration.

33. The method of claim 31, wherein the tissue annulus comprises a mitral valve annulus, and wherein introducing the tool distal end comprises inserting the tool distal end between valve structures of the mitral valve annulus and a ventricular wall of the heart.

34. The method of claim 31, further comprising:

introducing a prosthesis into the patient'"'"'s heart adjacent the tissue annulus;

securing the prosthesis to tissue adjacent the tissue annulus; and

removing the tool distal end from the tissue annulus.

35. The method of claim 34, wherein the prosthesis comprises one of an annular shape and a “

C”

shape.

36. The method of claim 35, wherein the tool distal end has a shape corresponding to the shape of the prosthesis to support tissue adjacent the tissue annulus while fasteners are delivered to secure the prosthesis to tissue adjacent the tissue annulus.

37. The method of claim 31, further comprising:

securing the tool distal end to tissue adjacent the tissue annulus; and

releasing the tool distal end from a handle of the tool.